Pre- Conditioning Infection Assessment

*The timeline requirements for this form are as follows:
Assessment Time Frame: Screening through initiation of conditioning
Submission Time Frame: Within 5 days of conditioning

Were any infections diagnosed or treated between screening and the initiation of conditioning?:
Report if any infections were diagnosed from the time of screening through initiation of conditioning as Yes or No.

Was subject treated with antimicrobial therapy between screening and the initiation of conditioning?:
This field will only appear in the EDC if “Were any infections diagnosed or treated between screening and the initiation of conditioning?” is answered Yes. Indicate if the subject was treated with antimicrobial therapy from the time of screening through initiation of conditioning as Yes or No.

Note: Antimicrobial pharmaceutical and cellular therapies used to treat Grade II-III infections are permitted (see protocol 7.9.2 Permitted Concomitant Therapy). These therapies must be reported on the Medications CRF.

Report a new section in the pre-conditioning infection assessment details below to capture each infection between screening and the initiation of conditioning

This section will appear if “Were any infections diagnosed or treated between screening and the initiation of conditioning” is answered Yes. This sections allows for up to 100 infections to be reported.

Pathogen Type:
Indicate the pathogen type related to the observed infection by selecting one of the following options:
• Bacterial
• Fungal
• Viral
• Parasitic
• Other pathogen type, specify

Organism:
This field will only appear in the EDC if “Pathogen” is answered Bacterial, Fungal, Viral or Parasitic. Select the organism from the pathogen-specific list.

If one of the following are selected, completed the “Other, specify” free textbox which populates below this field (up to 200 characters).
• Other Bacterial Infection, Specify
• Other Fungal Infection, Specify
• Other Viral Infection, Specify
• Other Parasitic Infection, Specify

Specify other pathogen type:
This field will only appear in the EDC if “Pathogen Type” is answered Other pathogen type, specify. Report the pathogen type in this free textbox (up to 200 characters).

Other Pathogen, Specify Organism:
This field will only appear in the EDC if “Pathogen Type” is answered Other pathogen type, specify. Report the pathogen’s organism in this free textbox (up to 200 characters).

Infection Site (1, 2, 3, 4, 5):
Select the site(s) of infection from the options below. Each site must be indicated in its own field (with a maximum of 5 sites reported). If infection is only present in one site, leave Infection Site 2-5 fields blank.
• Blood
• Bone
• CNS
• Eyes
• Genital Area
• GI tract, Lower
• GI tract, Upper
• Joints
• Liver/Spleen
• Lung
• Sinus and/or upper respiratory tract
• Skin, cellulitis
• Skin, necrotizing fasciitis
• Urinary tract, Lower
• Urinary tract, Upper

Date of Diagnosis:
Report the date of this infection was first observed (clinically, or by testing) in DD/MMM/YYYY format.
If the date entered is a future date, a query will appear in the EDC.

BMT CTN infection grading:
Report the BMT CTN severity grade at Date of Diagnosis as Grade 2 or Grade 3. Refer to platform protocol for BMT CTN infection grading guidelines.

Was treatment administered for this infection?:
Report if treatment was administered for this infection as Yes or No.

If treatment was administered, report all treatments on the Concomitant Medications form and linked to this page.

If a medication is given for treatment of an infection, the appropriate Concomitant Medications form can be linked directly to the Infection form.

To add a link to a Concomitant Medications form, you must first have entered the Concomitant Medications form to report the medication. Next, on the Pre-Conditioning Infection Assessment form click +Add Link under the Concomitant Medications heading. In the pop-up window, select the Concomitant Medications to link by clicking on the checkbox to the left of the Reference # then click Save.

How was infection diagnosed

Select at least one of the following methods of diagnoses from the options below.

• Clinical
• Radiographic
• Microbiologic
• Molecular diagnostic test (if selected, please select one of the following)_
  • PCR
  • Antigen testing
  • Next generation sequencing testing
  • Film array
  • Other molecular test, specify
    • Specify other molecular test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]
• Other diagnostic test, specify
  • Specify other diagnostic test [This field will only appear in the EDC if “Other diagnostic test, specify” is selected. Report the test in this free textbox (up to 200 characters).]

Maximum BMT CTN severity grade between screening and the initiation of conditioning:
Report the maximum BMT CTN severity grade observed from the time of screening through initiation of conditioning as Grade 1, Grade 2 or Grade 3, per platform protocol Appendix D: BMT CTN Infection Grading.

Infection ongoing at time of conditioning initiation:
Indicate if this infection was ongoing when the first conditioning regimen agent was administered.

!NOTE: Any infections which meet protocol-defined reporting requirements and persist after conditioning is initiated must be reported on the Adverse Event form.

Date of resolution:
This field will appear and is required if “Infection ongoing at time of conditioning regimen” is answered No. Report the date this infection resolved in DD/MMM/YYYY format.

BMT CTN severity grade at the initiation of conditioning:
Report the BMT CTN severity grade observed when the first conditioning regimen agent was administered as Grade 1, Grade 2 or Grade 3, per platform protocol Appendix D – BMT CTN Infection Grading.

For anti-fungal infections requiring treatment: Azoles (e.g., posaconazole or voriconazole) must be delayed from beginning of conditioning through completion of D4 PTCy dose to avoid potential drug-drug interactions with cyclophosphamide that could lead to increased toxicity.

Method of confirming infection resolution (check all that apply)

This section will appear if “Infection ongoing at time of conditioning initiation” is answered No.

Select at least one of the following methods used to confirm infection resolution from the options below.

• Clinical
• Radiographic
• Microbiologic
• Molecular diagnostic test (if selected, please select one of the following)
  • PCR
  • Antigen testing
  • Next generation sequencing test
  • Film array
  • Other molecular test, specify
    • Specify other molecular test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]
• Other diagnostic test, specify
  • Specify other diagnostic test [This field will only appear in the EDC if “Other molecular test, specify” is selected. Report the test in this free textbox (up to 200 characters).]

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